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A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability

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ClinicalTrials.gov Identifier: NCT01404117
Recruitment Status : Withdrawn (Study is being redesigned)
First Posted : July 27, 2011
Last Update Posted : August 27, 2013
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries

Tracking Information
First Submitted Date  ICMJE July 26, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date August 27, 2013
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Safety and efficacy [ Time Frame: 10 months ]
To assess the safety, tolerability and efficacy of laquinimod in RRMS
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Safety and Efficacy measurements [ Time Frame: 6 months ]
Number of subjects with adverse events, clinically significant abnormalities; proportion of subjects who prematurely discontinue
Change History Complete list of historical versions of study NCT01404117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Tolerability [ Time Frame: 10 months ]
To assess the safety, tolerability and efficacy of laquinimod in RRMS as compared to placebo, subjects treated with GA or an IFN-B preparation (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • Cumulative number of T1 Gd-enhancing lesions [ Time Frame: 6 months ]
    T1-weighted images
  • Cumulative number T2 lesions [ Time Frame: 6 months ]
  • Brain atrophy [ Time Frame: 6 months ]
    Defined by percentage of change from baseline to month 6 in brain volume
  • Cumulative number of new T1 hypointense lesions [ Time Frame: 6 months ]
    Enhanced T1-weight images
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multinational, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Assessing the Safety and Tolerability
Official Title  ICMJE Not Provided
Brief Summary A multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to assess the safety, tolerability and efficacy of two daily doses of oral laquinimod (0.6mg or 1.2mg) in adjunct to glatiramer acetate (GA) or interferon-beta (IFN-B) in relapsing remitting multiple sclerosis (RRMS) subjects
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Relapsing Multiple Sclerosis
Intervention  ICMJE
  • Drug: Laquinimod 0.6
    Laquinimod 0.6 capsule
  • Drug: Laquinimod 1.2
    Placebo
  • Other: Glatiramer Acetate or interferon-beta+ Placebo
    GA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo
Study Arms  ICMJE
  • Experimental: Laquinimod 0.6
    GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 0.6 mg
    Intervention: Drug: Laquinimod 0.6
  • Experimental: Laquinimod 1.2
    GA 20 mg/1mL or an IFN-B preparation + oral daily administration of laquinimod 1.2 mg
    Intervention: Drug: Laquinimod 1.2
  • Experimental: GA or IFN + Placebo
    GA 20 mg/1mL or an IFN-B preparation + oral daily placebo
    Intervention: Other: Glatiramer Acetate or interferon-beta+ Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 26, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2011)
200
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must have a documented MS diagnosis as defined by the Revised McDonald criteria [Ann Neurol 2011: 69:292-302], with a relapsing-remitting disease course.
  2. Subjects must be ambulatory with an EDSS score of 1-5.5 (inclusive) at the baseline visit.
  3. Subjects must be relapse-free and in a stable neurological condition and free of corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or oral] 30 days prior to screening (month -1).
  4. Subjects must be treated with either Copaxone® or an IFN-B preparation (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®), at a stable dose for at least 6 months prior to the screening visit (switching between IFN-B preparations during the 6 months prior to screening is allowed; switching between any IFN-B preparation and GA, or vice versa, is exclusionary).
  5. Subjects must have had experienced at least one documented relapse in the 36 weeks prior to randomization, with an incomplete recovery of the neurological functions as compared to pre-relapse status.
  6. Subjects must be between 18 and 55 years of age, inclusive.
  7. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch, long-acting injectable contraceptive or double-barrier method (condom or diaphragm with spermicide)].
  8. Subjects must be able to sign and date a written informed consent prior to entering the study.
  9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.

Exclusion Criteria:

  1. An onset of a relapse between Month -1 (Screening) and 0 (Baseline), unstable neurological condition or any treatment with corticosteroids [intravenous (IV), intramuscular (IM) and/or oral] or Adrenocorticotropic hormone.
  2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to Screening.
  3. Use of immunosuppressive including Mitoxantrone (Novantrone®) or cytotoxic agents within 6 months prior to the screening visit.
  4. Previous use of either of the following: natalizumab (Tysabri®), cladribine, laquinimod, and fingolimod (Gilenya®).
  5. Previous treatment with intravenous immunoglobulin (IVIG) within 2 months prior to screening visit.
  6. Systemic corticosteroid treatment of ≥30 consecutive days duration within 2 months prior to screening visit.
  7. Previous total body irradiation or total lymphoid irradiation.
  8. Previous stem cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
  9. Use of moderate/strong inhibitors of cytochrome P450 CYP3A4 within 2 weeks prior to the screening visit.
  10. Use of inducers of CYP3A4 within 2 weeks prior to the screening visit.
  11. Use of amiodarone within 2 years prior to screening visit.
  12. Pregnancy or breastfeeding.
  13. A ≥3xULN serum elevation of either alanine transaminase (ALT) or aspartate transaminase (AST) at screening.
  14. Serum direct bilirubin which is ≥2x upper limit of normal (ULN) at screening.
  15. Subjects with a potentially clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests or chest X-ray. Such conditions may include (but are not limited to):

    • A cardiovascular or pulmonary disorder that cannot be well-controlled by standard treatment permitted by the study protocol.
    • A gastrointestinal disorder that may affect the absorption of study medication.
    • Renal or metabolic diseases
    • Any form of acute or chronic liver disease
    • Known human immunodeficiency virus (HIV) positive status
    • A history of drug and/or alcohol abuse
    • An unstable psychiatric disorder.
    • A known history of tuberculosis.
    • Unstable psychiatric disorder
    • Any malignancies, excluding basal cell carcinoma (BCC), in the last 5 years.
  16. A glomerular filtration rate less than 60 ml/min at screening visit.
  17. A known history of sensitivity to gadolinium (Gd).
  18. Inability to successfully undergo MRI scanning.
  19. Previous endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
  20. Known drug hypersensitivity that would preclude administration of laquinimod, such as hypersensitivity to: mannitol, meglumine or sodium stearyl fumarate.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01404117
Other Study ID Numbers  ICMJE LAQ-MS-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries
Study Sponsor  ICMJE Teva Pharmaceutical Industries
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ralf Gold, MD
PRS Account Teva Pharmaceutical Industries
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP